A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

Response Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Other: Placebo; Drug: SLx-4090; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871936

SLx-4090-09-07

Details and patient eligibility

About

The purpose of this study is to determine whether SLx-4090 in combination with metformin therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin therapy alone.

Full description

1. HbA1c after 12 weeks
2. FPG after 12 weeks
3. Safety and tolerability
4. Plasma levels of SLx-4090

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HbA1c 7-11%
• On a stable dose of metformin for at least 6 weeks

Exclusion criteria

• Type 1 Diabetes
• Antidiabetic medication other than or in addition to metformin
• FPG > 270 mg/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

1

Experimental group

Description:

SLx-4090 in combination with Metformin

Treatment:

Drug: SLx-4090

Drug: Metformin

2

Other group

Description:

Placebo

Treatment:

Drug: Metformin

Other: Placebo